Trial Outcomes & Findings for Harnessing Health IT for Self-Management Support and Medication Activation in a Medicaid Health Plan (NCT NCT00683020)

NCT ID: NCT00683020

Last Updated: 2013-05-15

Results Overview

The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome. Change is calculated as 6-month score minus baseline score.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

362 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2013-05-15

Participant Flow

The study sample was drawn from San Francisco Health Plan The study sample was drawn April 2009 - March 2011 from San Francisco Health Plan (SFHP) members who received primary care at one of four publicly-funded clinics in the Community Health Network of San Francisco (CHNSF).

SFHP members deemed eligible were English-, Cantonese-, or Spanish-speaking adults (age 18 or above) with ≥1 primary care clinic visit in the preceding 24 months, had diabetes diagnosis, and access to a touch-tone phone. Members who were pregnant, unable to provide verbal consent, or leaving the region in the next 12 months were ineligible.

Participant milestones

Participant milestones
Measure
ATSM Intervention
ATSM Intervention: Automated Telephone Self-Management Support.
WAIT LIST Control
WAIT LIST Control: six month Wait List.
Overall Study
STARTED
182
180
Overall Study
COMPLETED
127
125
Overall Study
NOT COMPLETED
55
55

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Harnessing Health IT for Self-Management Support and Medication Activation in a Medicaid Health Plan

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
ATSM Intervention
n=127 Participants
ATSM Intervention: Automated Telephone Self-Management Support.
WAIT LIST Control
n=125 Participants
WAIT LIST Control: six month Wait List.
Total
n=252 Participants
Total of all reporting groups
Age Continuous
56.5 years
STANDARD_DEVIATION 7.9 • n=5 Participants
55.0 years
STANDARD_DEVIATION 8.6 • n=7 Participants
55.7 years
STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male
Female
98 Participants
n=5 Participants
89 Participants
n=7 Participants
187 Participants
n=5 Participants
Sex: Female, Male
Male
29 Participants
n=5 Participants
36 Participants
n=7 Participants
65 Participants
n=5 Participants
Race/Ethnicity, Customized
Latino
32 Participants
n=5 Participants
25 Participants
n=7 Participants
57 Participants
n=5 Participants
Race/Ethnicity, Customized
Black / African-American
7 Participants
n=5 Participants
12 Participants
n=7 Participants
19 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian / Pacific Islander
77 Participants
n=5 Participants
78 Participants
n=7 Participants
155 Participants
n=5 Participants
Race/Ethnicity, Customized
White / Caucasian
7 Participants
n=5 Participants
9 Participants
n=7 Participants
16 Participants
n=5 Participants
Race/Ethnicity, Customized
Multi-Ethnic / Other
4 Participants
n=5 Participants
1 Participants
n=7 Participants
5 Participants
n=5 Participants
Birth Place
Outside U.S.
110 Participants
n=5 Participants
106 Participants
n=7 Participants
216 Participants
n=5 Participants
Birth Place
Inside U.S.
17 Participants
n=5 Participants
19 Participants
n=7 Participants
36 Participants
n=5 Participants
Language
Cantonese
69 Participants
n=5 Participants
69 Participants
n=7 Participants
138 Participants
n=5 Participants
Language
Spanish
25 Participants
n=5 Participants
23 Participants
n=7 Participants
48 Participants
n=5 Participants
Language
English
33 Participants
n=5 Participants
33 Participants
n=7 Participants
66 Participants
n=5 Participants
Language Concordance with Primary Care Provider
Concordant
33 Participants
n=5 Participants
26 Participants
n=7 Participants
59 Participants
n=5 Participants
Language Concordance with Primary Care Provider
Discordant
57 Participants
n=5 Participants
62 Participants
n=7 Participants
119 Participants
n=5 Participants
Educational Attainment
8th grade education or less
50 Participants
n=5 Participants
58 Participants
n=7 Participants
108 Participants
n=5 Participants
Educational Attainment
Some high school
13 Participants
n=5 Participants
12 Participants
n=7 Participants
25 Participants
n=5 Participants
Educational Attainment
High school graduate or GED
33 Participants
n=5 Participants
22 Participants
n=7 Participants
55 Participants
n=5 Participants
Educational Attainment
College graduate or above
31 Participants
n=5 Participants
33 Participants
n=7 Participants
64 Participants
n=5 Participants
Health Literacy
Limited
58 Participants
n=5 Participants
50 Participants
n=7 Participants
108 Participants
n=5 Participants
Health Literacy
Adequate
68 Participants
n=5 Participants
75 Participants
n=7 Participants
143 Participants
n=5 Participants
Employment Status
Employed full-time
28 Participants
n=5 Participants
26 Participants
n=7 Participants
54 Participants
n=5 Participants
Employment Status
Part-time
63 Participants
n=5 Participants
58 Participants
n=7 Participants
121 Participants
n=5 Participants
Employment Status
Unemployed
12 Participants
n=5 Participants
15 Participants
n=7 Participants
27 Participants
n=5 Participants
Employment Status
Disabled
7 Participants
n=5 Participants
13 Participants
n=7 Participants
20 Participants
n=5 Participants
Employment Status
Homemaker / Retired / Other
17 Participants
n=5 Participants
13 Participants
n=7 Participants
30 Participants
n=5 Participants
Annual Household Income
≤ $20,000
73 Participants
n=5 Participants
75 Participants
n=7 Participants
148 Participants
n=5 Participants
Annual Household Income
$20,001 - $30,000
24 Participants
n=5 Participants
25 Participants
n=7 Participants
49 Participants
n=5 Participants
Annual Household Income
>$30,000
19 Participants
n=5 Participants
19 Participants
n=7 Participants
38 Participants
n=5 Participants
Financial Class - Insurance Type
Medicaid
28 Participants
n=5 Participants
22 Participants
n=7 Participants
50 Participants
n=5 Participants
Financial Class - Insurance Type
Medicare
4 Participants
n=5 Participants
7 Participants
n=7 Participants
11 Participants
n=5 Participants
Financial Class - Insurance Type
Uninsured / Commercial
1 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
Financial Class - Insurance Type
Healthy Worker / Healthy San Francisco
93 Participants
n=5 Participants
94 Participants
n=7 Participants
187 Participants
n=5 Participants
Diabetes Duration
6.9 Years
STANDARD_DEVIATION 5.9 • n=5 Participants
7.2 Years
STANDARD_DEVIATION 5.4 • n=7 Participants
7.0 Years
STANDARD_DEVIATION 5.7 • n=5 Participants
Insulin Treatment
Yes
25 Participants
n=5 Participants
18 Participants
n=7 Participants
43 Participants
n=5 Participants
Insulin Treatment
No
102 Participants
n=5 Participants
107 Participants
n=7 Participants
209 Participants
n=5 Participants
Hemoglobin A1c
> 8.0%
37 Participants
n=5 Participants
29 Participants
n=7 Participants
66 Participants
n=5 Participants
Hemoglobin A1c
≤ 8.0%
87 Participants
n=5 Participants
90 Participants
n=7 Participants
177 Participants
n=5 Participants
Hemoglobin A1c
7.8 %
STANDARD_DEVIATION 1.6 • n=5 Participants
7.5 %
STANDARD_DEVIATION 1.3 • n=7 Participants
7.7 %
STANDARD_DEVIATION 1.5 • n=5 Participants
Systolic Blood Pressure
127.3 mm Hg
STANDARD_DEVIATION 17.3 • n=5 Participants
128.1 mm Hg
STANDARD_DEVIATION 18.2 • n=7 Participants
127.7 mm Hg
STANDARD_DEVIATION 17.7 • n=5 Participants
Diastolic Blood Pressure
72.9 mm Hg
STANDARD_DEVIATION 9.3 • n=5 Participants
76.1 mm Hg
STANDARD_DEVIATION 9.9 • n=7 Participants
74.5 mm Hg
STANDARD_DEVIATION 9.7 • n=5 Participants
Low-density Lipoprotein
92.7 mg/dL
STANDARD_DEVIATION 30.3 • n=5 Participants
93.5 mg/dL
STANDARD_DEVIATION 31.5 • n=7 Participants
93.1 mg/dL
STANDARD_DEVIATION 30.8 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.

The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome. Change is calculated as 6-month score minus baseline score.

Outcome measures

Outcome measures
Measure
ATSM Intervention
n=119 Participants
ATSM Intervention: Automated Telephone Self-Management Support.
WAIT LIST Control
n=119 Participants
WAIT LIST Control: six month Wait List.
Changes in the Physical Component Summary of the SF-12 Health Survey
1.3 units on a scale
Standard Error 0.7
-0.7 units on a scale
Standard Error 0.7

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.

The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome. Change is calculated as 6-month score minus baseline score.

Outcome measures

Outcome measures
Measure
ATSM Intervention
n=119 Participants
ATSM Intervention: Automated Telephone Self-Management Support.
WAIT LIST Control
n=119 Participants
WAIT LIST Control: six month Wait List.
Changes in the Mental Component Summary of the SF-12 Health Survey
1.4 units on a scale
Standard Error 0.8
0.0 units on a scale
Standard Error 0.8

SECONDARY outcome

Timeframe: 6 months

Population: The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.

A measure of patients' functional status is ascertained by asking patients the following question: "In the last 30 days, how many days did health problems keep you in bed for all or most of the day?" Number of days may range from 0 to 30, with lower number of days indicating better functional status. Because a negative binomial model was used to analyze the data for number of days spent in bed due to illness, log means are reported. A log mean is the natural (base e) logarithm of the mean (in this context specifically, the mean number of days spent in bed due to illness). To calculate the mean, one raises e by the number given as the log mean. Lower log means indicate better functional status.

Outcome measures

Outcome measures
Measure
ATSM Intervention
n=127 Participants
ATSM Intervention: Automated Telephone Self-Management Support.
WAIT LIST Control
n=124 Participants
WAIT LIST Control: six month Wait List.
Number of Days Spent in Bed Due to Illness
0.02 log days
95% Confidence Interval 0.3 • Interval 0.01 to 0.03
0.03 log days
95% Confidence Interval 0.3 • Interval 0.016 to 0.051

SECONDARY outcome

Timeframe: 6 months

Population: The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.

A measure of diabetes interference on patients is ascertained by asking patients the following question: "In the last 6 months, how often has your diabetes kept you from doing your normal daily activities, such as going to work, grocery shopping, and taking care of yourself and others?" Responses consist of 6 possible options: "Always", "Almost Always", "Often", "Sometimes", "Almost Never", and "Never". These responses are grouped into 2 categories, with one category consisting of "Always", "Almost Always", and "Often" responses while the other category consists of the remaining responses. The proportion of patients reporting diabetes interference is the number of patients in the first category divided by the number of patients in the 2 categories combined.

Outcome measures

Outcome measures
Measure
ATSM Intervention
n=127 Participants
ATSM Intervention: Automated Telephone Self-Management Support.
WAIT LIST Control
n=124 Participants
WAIT LIST Control: six month Wait List.
Proportion of Patients Reporting Diabetes Interference of Normal Daily Activities
0.039 proportion of patients
Interval 0.1 to 0.6
0.088 proportion of patients
Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.

The Summary of Diabetes Self-Care Activities (SDSCA) Measure is a brief self-report questionnaire on diabetes self-management behaviors. The questionnaire assesses the frequency with which a patient followed a diabetes routine over the prior 7 days in five domains: diet, exercise, blood-glucose testing, foot care, and medication adherence. Based on SDSCA measure's author's recommendations, two separate scores are derived: a Diabetes Self-management Behaviors score and a Self-reported Medication Adherence score. For the Diabetes Self-management Behaviors score, all items pertaining to diet, exercise, blood glucose testing, and foot care are averaged. For the Self-reported Medication Adherence score, all items pertaining to medication use are averaged. For both scores, the result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior or better medication adherence. Change is calculated as 6-month score minus baseline score.

Outcome measures

Outcome measures
Measure
ATSM Intervention
n=127 Participants
ATSM Intervention: Automated Telephone Self-Management Support.
WAIT LIST Control
n=125 Participants
WAIT LIST Control: six month Wait List.
Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale
0.7 units on a scale
Standard Error 0.4
0.08 units on a scale
Standard Error 0.08

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.

The Summary of Diabetes Self-Care Activities (SDSCA) Measure is a brief self-report questionnaire on diabetes self-management behaviors. The questionnaire assesses the frequency with which a patient followed a diabetes routine over the prior 7 days in five domains: diet, exercise, blood-glucose testing, foot care, and medication adherence. Based on SDSCA measure's author's recommendations, two separate scores are derived: a Diabetes Self-management Behaviors score and a Self-reported Medication Adherence score. For the Diabetes Self-management Behaviors score, all items pertaining to diet, exercise, blood glucose testing, and foot care are averaged. For the Self-reported Medication Adherence score, all items pertaining to medication use are averaged. For both scores, the result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior or better medication adherence. Change is calculated as 6-month score minus baseline score.

Outcome measures

Outcome measures
Measure
ATSM Intervention
n=122 Participants
ATSM Intervention: Automated Telephone Self-Management Support.
WAIT LIST Control
n=117 Participants
WAIT LIST Control: six month Wait List.
Changes in Self-reported Medication Adherence as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale
0.2 units on a scale
Standard Error 0.06
0.2 units on a scale
Standard Error 0.06

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.

The Patient Self-Management Scale was derived from a questionnaire used in the Diabetes Quality Improvement Project. The scale is designed to reflect patients' assessment of their ability to manage aspects of diabetes self-care in 5 separate areas (medication, diet, exercise, blood glucose monitoring, and foot care). Respondents are asked how difficult over the past 6 months has it been to follow exactly as their doctor who takes care of their diabetes suggested. Possible scores for each scale item range from 0 to 100 with higher score indicating more self-efficacy. Total scale score is calculated as the average across all items. Change is calculated as 6-month score minus baseline score.

Outcome measures

Outcome measures
Measure
ATSM Intervention
n=127 Participants
ATSM Intervention: Automated Telephone Self-Management Support.
WAIT LIST Control
n=125 Participants
WAIT LIST Control: six month Wait List.
Changes in Diabetes Self-efficacy as Measured by Diabetes Quality Improvement Project's Patient Self-Management Scale
6.8 units on a scale
Standard Error 1.1
5.7 units on a scale
Standard Error 1.1

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.

The Patient Assessment of Chronic Illness Care (PACIC) is a 20-item patient report instrument that measures patients' perspectives on the structure of their care and collects patient reports on the extent to which they have received specific clinical services and actions during the past 6 months that are aligned with the Chronic Care Model. The scale is intended to assess the receipt of care that is patient-centered, proactive, planned and includes collaborative goal setting, problem-solving and follow-up support. Each instrument item is scored on a 5-point scale ranging from 1 to 5 with higher score indicating better care. Scores are transformed to a 100-point scale (0-100) and averaged across all items to create a total scale score. Higher transformed and total scale scores indicate better care. Change is calculated as 6-month score minus baseline score.

Outcome measures

Outcome measures
Measure
ATSM Intervention
n=127 Participants
ATSM Intervention: Automated Telephone Self-Management Support.
WAIT LIST Control
n=125 Participants
WAIT LIST Control: six month Wait List.
Changes in Patient-centeredness of Care as Measured by Patient Assessment of Chronic Illness Care (PACIC) Scale
11.3 units on a scale
Standard Error 1.5
10.0 units on a scale
Standard Error 1.6

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.

The Interpersonal Processes of Care (IPC) is an 18-item patient report instrument that measures patients' perspectives on the structure of their care and collects patient reports on providers' communication over the prior 6 months. The scale is intended to measure patients' assessment of providers' communication within 3 broad domains: communication (e.g., lack of clarity), decision making (e.g., patient-centered decision making), and interpersonal style (e.g., friendliness). Each instrument item is scored on a 5-point scale ranging from 1 to 5. Scores are transformed to a 100-point scale and averaged across all items to create a total scale score. Higher total scores indicate better communication. Change is calculated as 6-month score minus baseline score.

Outcome measures

Outcome measures
Measure
ATSM Intervention
n=127 Participants
ATSM Intervention: Automated Telephone Self-Management Support.
WAIT LIST Control
n=125 Participants
WAIT LIST Control: six month Wait List.
Changes in Patient-centeredness of Care as Measured by Interpersonal Processes of Care (IPC) Scale
-1.8 units on a scale
Standard Error 0.9
-3.8 units on a scale
Standard Error 0.9

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.

Hemoglobin A1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. As the average amount of plasma glucose increases, the fraction of hemoglobin A1c increases in a predictable way. This serves as a marker for average blood glucose levels over the previous months prior to the measurement. Higher amounts of hemoglobin A1c indicate poorer control of blood glucose levels and have been associated with cardiovascular disease. Change is calculated as 6-month level minus baseline level.

Outcome measures

Outcome measures
Measure
ATSM Intervention
n=56 Participants
ATSM Intervention: Automated Telephone Self-Management Support.
WAIT LIST Control
n=50 Participants
WAIT LIST Control: six month Wait List.
Changes in Hemoglobin A1c Levels
-0.5 percentage
Standard Error 0.1
-0.2 percentage
Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.

Systolic blood pressure is the pressure exerted on arteries and vessels by the heart when it contracts and pushes blood through the arteries to the rest of the body. Change is calculated as 6-month pressure minus baseline pressure.

Outcome measures

Outcome measures
Measure
ATSM Intervention
n=79 Participants
ATSM Intervention: Automated Telephone Self-Management Support.
WAIT LIST Control
n=88 Participants
WAIT LIST Control: six month Wait List.
Changes in Systolic Blood Pressure (SBP)
0.2 mm Hg
Standard Error 1.7
-0.4 mm Hg
Standard Error 1.6

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.

Diastolic blood pressure is the pressure exerted on the walls of the arteries and vessels in between heart beats, when the heart is relaxed and dilated, filling with blood. Change is calculated as 6-month pressure minus baseline pressure.

Outcome measures

Outcome measures
Measure
ATSM Intervention
n=79 Participants
ATSM Intervention: Automated Telephone Self-Management Support.
WAIT LIST Control
n=88 Participants
WAIT LIST Control: six month Wait List.
Changes in Diastolic Blood Pressure (DBP)
1.2 mm Hg
Standard Error 1.0
-0.9 mm Hg
Standard Error 1.0

Adverse Events

ATSM Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

WAIT LIST Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dean Schillinger, MD/Study Principal Investigator

University of California, San Francisco

Phone: 415-206-8940

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place